The U.S. Food and Drug Administration (FDA) is taking action on regulating genetic testing kits. The agency has sent letters to several manufacturers of genetic testing kits, notifying the companies that the kits may be subject to premarket approval procedures, or an approved application for an investigational device exemption. The letters come shortly after the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations requested information from several companies about the kits. (See DM 12760.)

The FDA has determined that the companies' test kits are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act, because the kits are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

The companies are Knome, Inc. (the Knome COMPLETE), 23andMe, Inc. (the 23andMe Personal Genome Service), decode Genetics (the deCODEme Complete Scan), Illumina, Inc. (Infinium HumanHap550), and Navigenics (Navigenics Health Compass). In the letters, the FDA also states that for devices requiring premarket approval, a notice is required when intending to introduce the device into commercial distribution. The letter to 23andMe specifically notes that the company has begun distributing the collection kit for its Personal Genome Service device through a third party distributor, Amazon.com.
In May, the FDA had sent a similar letter to Pathway Genomics Corporation concerning the Pathway Genomics Genetic Health Report, asking for an FDA clearance or approval number for the Genetic Health Report, or to explain why the kit does not need FDA clearance or approval.

The letters recommend prompt response to discuss the issue of FDA review.

The FDA letters can be found at: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm111104.htm

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